Hidradenitis SuppurativaPhase 2NCT05040698
Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
A Phase 2 study testing Fostamatinib in people with Hidradenitis Suppurativa, run by Holdsworth House Medical Practice at 1 site in Australia.
Trial summary
A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Fostamatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Oct 2021to 27 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI
Who cannot join
- Uncontrolled hypertension (systolic blood pressure [BP] ≥135 mmHg and/or diastolic BP ≥85 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia) at screening.
- History of myocardial infarction within 3 months prior to screening.
- Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine at screening or at randomization.
- Renal function impairment with creatinine clearance <30 mL/min at screening (estimated glomerular filtration rate will be calculated using the modification of diet in renal disease equation).
- Liver function impairment with aspartate aminotransferase/alanine aminotransferase >=3x the upper limit of normal or bilirubin >2X the upper limit of normal at screening.
- Neutrophil count <1000/µL at screening.
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- History of an allergic reaction or hypersensitivity to the study treatment or any component of the study treatment formulation.
- Has documented HIV infection or documented, active hepatitis B or hepatitis C infection.
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
- Individuals with concurrent use of systemic antibiotics/ oral retinoids/ systemic immunosuppressants (those with prior use of these medications must have conducted a washout period of 4 weeks or 5 half-lives of the drug, whichever is longer).
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
About this study
Official title: An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.
Read the detailed description
Sample size: 20 patients Study duration: 16 weeks
Primary Endpoints:
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to Baseline.
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline.
Secondary Endpoints:
Safety and Tolerability (Grade 2/3 Adverse Effects); Changes in Disease Activity (Measures by AN count and IHS4 scoring).
Study procedures Clinical Examination, Patient Questionnaires, Skin Biopsy, Blood Draw, medical photography
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Fostamatinib
- Keywords
- fostamatinib, HS, Tavalisse
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostamatinibDrug
Also called Tavalisse, R935788
Open label Fostamatinib
| Study group | Role | What they receive |
|---|---|---|
| Open Label Fostamatinib | Experimental | Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1 Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Week 4 evaluation
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Measured: 4 weeks
Week 12 evaluation
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
Measured: 12 weeks
Secondary outcomes (7)
Grade 2/3 Adverse Events
Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.
Measured: 12 weeks
Abscess and Nodule Count Week 4
Changes in Abscess and Nodule count at Week 4 compared to baseline
Measured: 4 weeks
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
Changes in IHS4 score at Week 4 compared to baseline
Measured: 4 weeks
Abscess and Nodule count week 12
Changes in Abscess and Nodule count at Week 12 compared to baseline
Measured: 12 weeks
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
Changes in IHS4 score at Week 12 compared to baseline
Measured: 12 weeks
Physician Rated Overall Disease Severity
Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline
Measured: 12 weeks
Dermatology Life Quality Index (DLQI)
Changes in the DLQI (0-30) at week 12 compared to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Oct 2021
- Primary completion13 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Collaborators
- Rigel Pharmaceuticals
- Responsible party
- Principal investigator, John Frew, Holdsworth House Medical Practice
- Investigators
- John Frew, MBBS, Principal investigator, Holdsworth House Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040698
- Sponsor's protocol ID
- JFR-001
- Status last verified
- Feb 2023
- First submitted
- 30 Aug 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flora A, Jepsen R, Kozera EK, Woods JA, Cains GD, Radzieta M, Jensen SO, Malone M, Frew JW. Mast cells are upregulated in hidradenitis suppurativa tissue, associated with epithelialized tunnels and normalized by spleen tyrosine kinase antagonism. Exp Dermatol. 2024 Jan;33(1):e14894. doi: 10.1111/exd.14894. Epub 2023 Jul 31.
PubMed 37522746
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT05040698
- Acronym / sponsor ID
- JFR-001
- Conditions
- Hidradenitis Suppurativa
- Keywords
- fostamatinib, HS, Tavalisse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Collaborators
- Rigel Pharmaceuticals
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.
Detailed description
Sample size: 20 patients Study duration: 16 weeks
Primary Endpoints:
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to Baseline.
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline.
Secondary Endpoints:
Safety and Tolerability (Grade 2/3 Adverse Effects); Changes in Disease Activity (Measures by AN count and IHS4 scoring).
Study procedures Clinical Examination, Patient Questionnaires, Skin Biopsy, Blood Draw, medical photography
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Fostamatinib | Experimental | Drug: FostamatinibOpen label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI
Key exclusion criteria (11 listed)
- Uncontrolled hypertension (systolic blood pressure [BP] ≥135 mmHg and/or diastolic BP ≥85 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia) at screening.
- History of myocardial infarction within 3 months prior to screening.
- Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine at screening or at randomization.
- Renal function impairment with creatinine clearance <30 mL/min at screening (estimated glomerular filtration rate will be calculated using the modification of diet in renal disease equation).
- Liver function impairment with aspartate aminotransferase/alanine aminotransferase >=3x the upper limit of normal or bilirubin >2X the upper limit of normal at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FostamatinibAlso: Tavalisse, R935788Open label Fostamatinib | Drug | Open Label Fostamatinib |
Primary outcome
Week 4 evaluation
Time frame: 4 weeks
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Week 12 evaluation
Time frame: 12 weeks
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
7 secondary outcomes
Grade 2/3 Adverse Events
Time frame: 12 weeks
Abscess and Nodule Count Week 4
Time frame: 4 weeks
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
Time frame: 4 weeks
Abscess and Nodule count week 12
Time frame: 12 weeks
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
Time frame: 12 weeks
Physician Rated Overall Disease Severity
Time frame: 12 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 37522746Flora A, Jepsen R, Kozera EK, Woods JA, Cains GD, Radzieta M, Jensen SO, Malone M, Frew JW. Mast cells are upregulated in hidradenitis suppurativa tissue, associated with epithelialized tunnels and normalized by spleen tyrosine kinase antagonism. Exp Dermatol. 2024 Jan;33(1):e14894. doi: 10.1111/exd.14894. Epub 2023 Jul 31.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Frew, MBBS principal investigator
Holdsworth House Medical Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib in people with Hidradenitis Suppurativa, run by Holdsworth House Medical Practice at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Week 4 evaluation (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.